This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \<17 years of age undergoing MRI scans in the US and Japan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
128
dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan
propofol IV administration will be given if needed to maintain sedation
Arkansas Children's
Little Rock, Arkansas, United States
Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age
In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.
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Lucile Packard Children's Hospital, Stanford
Palo Alto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Baptist Health - Wolfson Children's Hospital
Jacksonville, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
IU Health Riley Hospital for Children
Indianapolis, Indiana, United States
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
M Health Fairview University of Minnesota Medical Center - West Bank
Minneapolis, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 13 more locations
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age
Participants who did not have PRO administered were censored.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Emergence Time - By Age Cohort and Combined Age
Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.
Time frame: Post MRI scan on Day 1 up to 24 hours
Number of Participants Who Received PRO - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1